Female sex pill makes comeback
Women suffering from low libido got some hope last Thursday, when a panel of health experts said the government should approve an experimental pill intended to boost sexual desire. It is the first time a government panel has endorsed such a drug. The move surprised many experts, because the Food and Drug Administration has twice rejected the drug due to lacklustre effectiveness and worrisome side effects.How does the drug work?Who would take this drug?Is the drug effective?What are the side effects?
The FDA will make a formal decision later this summer. But many analysts say the panel’s backing could clear the way for the first drug approved to treat a female sexual disorder. Drugmakers have been trying to cultivate that market since the blockbuster launch of Viagra for men in the late 1990s. Ahead of Thursday’s meeting, women’s groups and other advocates lobbied for the pill’s approval, saying women’s sexual problems have been overlooked for too long by the federal government.
Here’s a look at the pill flibanserin from Sprout Pharmaceuticals, which some have dubbed “Female Viagra.”
Flibanserin acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. In fact, it was originally studied as a treatment for severe depression before being repurposed into a libido drug. It’s not entirely clear why flibanserin increases sexual desire but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin — another chemical linked with feelings of satiation.
Sprout wants to market the drug to premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
Surveys estimate that between 5.5 million to 8.6 million US women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship problems, medical conditions, depression and mood issues caused by other medications like sleeping aids and painkillers.
The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.
Experts usually describe flibanserin’s effect as “modest.” In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress.
While FDA scientists describe these effects as “small,” they were significant enough to meet FDA effectiveness standards.
The FDA panellists acknowledged that flibanserin will not help all patients. The percentage of patients reporting positive results with flibanserin was only 10 to 15 percent higher than among patients taking a placebo. That suggests as few as 1 in 10 patients may actually benefit from the drug, according to some FDA advisers.
Flibanserin’s side effects have hampered its review at the FDA for years. About 10 percent of patients in Sprout’s studies experienced the most common problems: dizziness, fatigue and nausea.
